Finding studies
Finding studies
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Lead
St. Jude Children's Research Hospital
With
OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered during and after radiotherapy in young patients with newly diagnosed high-grade glioma and unfavorable low-grade glioma. * Determine the 1- and 2-year progression-free survival of patients treated with this regimen. Secondary * Determine the toxic effects of this regimen in these patients. * Correlate genetic abnormalities in epidermal growth factor receptor (EGFR) and components of downstream pathways with treatment response in patients treated with this regimen. * Determine the ability of erlotinib to inhibit EGFR signaling in patients with high-grade glioma who require second surgery. * Determine the pharmacokinetics of erlotinib and its metabolites in these patients. * Correlate plasma and cerebrospinal fluid levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor response in patients treated with this regimen. * Correlate irradiation dosimetry with patterns of failure, standard and investigational imaging, and toxicity in patients treated with this regimen. OUTLINE: This is a phase I dose-escalation study of erlotinib followed by a phase II study. * Phase I: Patients undergo radiotherapy once daily, 5 days week, for approximately 6½ weeks. Beginning on the first day of radiotherapy, patients receive oral erlotinib once daily for up to 2 years. Cohorts of patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. * Phase II: Patients will receive erlotinib as in phase I at the MTD and undergo radiotherapy as in phase I. PROJECTED ACCRUAL: A total of 75-80 patients (15-20 for the phase I portion and 60 for the phase II portion) will be accrued for this study.
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
